Lead Auditor
Our in-depth course will provide all the resources you need to operate as a lead auditor
Upcoming Virtual Courses
Overview
For years, AAMI courses have been the gold standard for training on the implementation of FDA 21 CFR Part 820 Quality System Regulation and ANSI/AAMI/ISO 13485: 2016/(R)2019. Now, auditors can also benefit from the expertise and rigor of AAMI faculty as they learn today’s best practices for conducting internal audits and supplier audits for compliance with FDA, ISO, MDSAP and EU MDR requirements. We’ll also provide coverage of ASQ/ANSI/ISO 19011:2018, Guidelines For Auditing Management Systems.
What to expect
Over two information-packed, interactive days, participants will learn:
- Current requirements for internal audits in today's international medical device market
- Best practices in the interpretation and application of AAMI and other standards
- How to conduct effective “remote/virtual” QMS audits.
- Hands-on advice on how to meet FDA expectations for audit procedures, auditor qualifications and audit records
- The latest on MDSAP and EU MDR status and best practices for working with Notified Bodies
Materials
Registration includes:
- a copy of ANSI/AAMI/ISO 13485: 2016/(R)2019 (a $249 retail value)
- OnDemand access to the recordings following the event (you don’t have to be available live to take advantage of all the learning)
- a QMS auditing exam qualification record
- access to the AAMI Alumni community group
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.